September 24, 2020 | Hiddo J.L. Heerspink, Ph.D., Bergur V. Stefánsson, M.D., Ricardo Correa-Rotter, M.D., Glenn M. Chertow, M.D., Tom Greene, Ph.D., Fan-Fan Hou, M.D., Johannes F.E. Mann, M.D., John J.V. McMurray, M.D., Magnus Lindberg, M.Sc., Peter Rossing, M.D., C. David Sjöström, M.D., Roberto D. Toto, M.D., Anna-Maria Langkilde, M.D., and David C. Wheeler, M.D., for the DAPA-CKD Trial Committees and Investigators
The DAPA-CKD trial evaluated the effects of dapagliflozin, an SGLT2 inhibitor, in patients with chronic kidney disease (CKD), with or without type 2 diabetes. A total of 4304 participants with an estimated glomerular filtration rate (eGFR) of 25 to 75 ml/min/1.73 m² and a urinary albumin-to-creatinine ratio (UACR) of 200 to 5000 were randomly assigned to receive either dapagliflozin (10 mg/day) or placebo. The primary outcome was a composite of a sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
Over a median follow-up of 2.4 years, the primary outcome occurred in 197 (9.2%) of 2152 participants in the dapagliflozin group and 312 (14.5%) in the placebo group, with a hazard ratio of 0.61 (95% CI, 0.51 to 0.72; P<0.001). The hazard ratio for the composite of a sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P=0.009). The hazard ratio for all-cause mortality was 0.69 (95% CI, 0.53 to 0.88; P=0.004). Dapagliflozin showed similar efficacy in patients with and without type 2 diabetes.
The trial was stopped early due to efficacy, with no significant safety issues reported. Dapagliflozin demonstrated a significant reduction in the risk of the primary composite outcome, including a lower risk of death from renal or cardiovascular causes, and a lower risk of hospitalization for heart failure. The safety profile of dapagliflozin was confirmed, with no cases of diabetic ketoacidosis and no severe hypoglycemia in non-diabetic patients.
The study confirms that dapagliflozin is effective in reducing the risk of kidney and cardiovascular events in patients with CKD, regardless of the presence of type 2 diabetes. The findings support the use of dapagliflozin as an addition to standard therapy in patients with CKD. The trial was funded by AstraZeneca andThe DAPA-CKD trial evaluated the effects of dapagliflozin, an SGLT2 inhibitor, in patients with chronic kidney disease (CKD), with or without type 2 diabetes. A total of 4304 participants with an estimated glomerular filtration rate (eGFR) of 25 to 75 ml/min/1.73 m² and a urinary albumin-to-creatinine ratio (UACR) of 200 to 5000 were randomly assigned to receive either dapagliflozin (10 mg/day) or placebo. The primary outcome was a composite of a sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
Over a median follow-up of 2.4 years, the primary outcome occurred in 197 (9.2%) of 2152 participants in the dapagliflozin group and 312 (14.5%) in the placebo group, with a hazard ratio of 0.61 (95% CI, 0.51 to 0.72; P<0.001). The hazard ratio for the composite of a sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P=0.009). The hazard ratio for all-cause mortality was 0.69 (95% CI, 0.53 to 0.88; P=0.004). Dapagliflozin showed similar efficacy in patients with and without type 2 diabetes.
The trial was stopped early due to efficacy, with no significant safety issues reported. Dapagliflozin demonstrated a significant reduction in the risk of the primary composite outcome, including a lower risk of death from renal or cardiovascular causes, and a lower risk of hospitalization for heart failure. The safety profile of dapagliflozin was confirmed, with no cases of diabetic ketoacidosis and no severe hypoglycemia in non-diabetic patients.
The study confirms that dapagliflozin is effective in reducing the risk of kidney and cardiovascular events in patients with CKD, regardless of the presence of type 2 diabetes. The findings support the use of dapagliflozin as an addition to standard therapy in patients with CKD. The trial was funded by AstraZeneca and